Clinical trial · Interventional
Efficacy of Thoracic Paravertebral Block in the Reduction of Acute Post-surgical Pain in Patients With Breast Cancer
Efficacy of Thoracic Paravertebral Block vs Local Anesthesia of the Surgical Wound in Reduction of Acute Post-surgical Pain in Patients With Breast Cancer. Controlled Phase III, Randomized, Single-blind, Superiority Clinical Trial.
NCT02609321CI-TRIAL-00025270completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surgical treatment of breast cancer is frequently associated with postoperative pain in the surgical area. Persistent pain after breast cancer management has considerable negative effects on the quality of life of survivors. The aim of this trials is to evaluate the efficacy of thoracic paravertebral block with bupivacine 0.5% in reducing the acute pain postmastectomy compare with surgical wound infiltration with bupivacaine 0.5%.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical Wound Infiltration | Procedure | — | UNRESOLVED |
| Thoracic Paravertebral Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Thoracic Paravertebral Block
- description
- to identify the thoracic T3, a parallel line 2.5 cm from the spinous process is drawn and in this place the ultrasound sensor is placed. Ultrasonograph image identifies the transverse process, the intercostal cost-transverse ligament, the pleura and lung. We proceed to insert a needle between the two corresponding transverse processes and positions after passing the cost-ligament posterior intercostal and transverse to the parietal pleura. After negative aspiration for blood, 0.5% bupivacaine anesthetic is administered at doses of 1.5 mg/kg slowly. The volume is defined by the anesthesiologist. The injection of anesthetic is displayed, as well as confirmation of the correct location of the needle because the volume injected above pushes the pleura.
- interventionNames
- Procedure: Thoracic Paravertebral Block
- type
- ACTIVE_COMPARATOR
- label
- Surgical Wound Infiltration
- description
- before the close of the skin, it proceeds to infiltrate the subcutaneous tissue and skin with 0.5% bupivacaine at doses of 1.5 mg/kg, generating the widest possible dissemination of the bupivacaine in the surgical area.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women older than 18 years. 2. Diagnosis of breast cancer requiring major elective surgery: unilateral mastectomy with or without axillary dissection; with or without axillary sentinel node biopsy; with or without immediate breast reconstruction. 3. Willingness to participate in the study during the follow-up period. Exclusion Criteria: 1. Metastatic breast carcinoma; tumor involvement of contra lateral breast or armpit determined by clinical or paraclinical studies. 2. Medical History of coagulopathy. 3. Consumption of anticoagulants. 4. Contraindication to NSAIDs or opioids. 5. Allergy to local anesthetics of amide type. 6. Infection a interventions sites (paravertebral block or area affected breast surgical wound) 7. Pregnancy and lactation. 8. BMI\>35. 9. Parkinson's disease, Alzheimer's disease or other diseases that affect the mental or motor sphere. 10. Double mastectomy or mastectomy history of previous ipsilateral to the current episode. 11. Preoperative risk classification ASA IV-V.
References
Publications (2)
- RESULTKairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87. PMID 15562083
- RESULTSidiropoulou T, Buonomo O, Fabbi E, Silvi MB, Kostopanagiotou G, Sabato AF, Dauri M. A prospective comparison of continuous wound infiltration with ropivacaine versus single-injection paravertebral block after modified radical mastectomy. Anesth Analg. 2008 Mar;106(3):997-1001, table of contents. doi: 10.1213/ane.0b013e31816152da. PMID 18292452